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Valneva wants to launch phase 3 trial with its anti-COVID vaccine this month

PARIS, Apr 6 (Reuters) – French pharmaceutical company Valneva reported positive results for its COVID-19 vaccine in the early phases of clinical trials on Tuesday and said it planned to launch a phase three clinical trial this month.

Valneva, using its licensed Japanese encephalitis vaccine technology, tested its immunization in 153 adults with three dose levels based on a two-dose schedule delivered at a three-week interval.

Group shares rose 8% in early trading.

The vaccine, according to the pharmacist, was “generally safe and well tolerated in all the dose groups tested, without an independent Data Safety Control Commission identifying safety problems.”

Valneva said that the vaccine, for which the US company Dynavax supplies an adjuvant, was also “highly immunogenic,” with “more than 90% of all study participants” developing significant levels of antibodies against the spikelet protein of the coronavirus.

“Based on the evaluated data, the company has decided to advance the high dose to the phase 3 clinical trial. Other trials, including booster ones, using antigen-sparing doses will also be evaluated,” Valneva said.

The company added that it was working with UK authorities to review plans, including the development and supply of possible variants of the vaccine.

Valneva has signed an agreement with the United Kingdom for the supply of up to 190 million doses until 2025, in an operation that could reach 1.4 billion euros (1.65 billion dollars). The company is also in talks with the European Union to supply it with 60 million doses.

The company said it intended to submit the vaccine for approval in the UK in the autumn of this year and said discussions with other regulatory bodies were ongoing.

(1 dollar = 0.8472 euros)

(Reported by Matthias Blamont; edited by Jason Neely, Kirsten Donovan, translated by Michael Susin at the Gdansk newsroom)

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